Trial record 3 of 490 for:    Open Studies | "Substance-Related Disorders"

Group Motivational Interviewing (GMI) For Homeless Veterans In VA Services (GMI in Vets)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2015 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT02233738
First received: August 21, 2014
Last updated: February 2, 2015
Last verified: January 2015
  Purpose

Homeless Veterans with substance use disorders (SUDs) are a major group served by VA and are heavily represented in VA housing. VA recently adopted a 'Housing First' approach emphasizing rapid housing placement to initiate recovery without requiring sobriety and will necessitate SUD interventions that are efficient and easily layered onto existing services. The proposed study will investigate the effectiveness, implementation process, and cost estimate of Group Motivational Interviewing (GMI) for Veterans with SUDs in VA housing (Housing Urban Development-VA Support Housing [HUD-VASH] and Grant and per Diem [GPD]). Outcomes will be assessed at multiple time points using a multi-modal approach. The ultimate goal of this research is to establish the basis of a GMI dissemination and implementation course of action for highly vulnerable homeless Veterans in VA housing for achieving their greatest success in attaining housing stability.


Condition Intervention
Alcoholism
Substance-related Disorders
Dual Diagnosis
Behavioral: Group Motivational Interviewing (GMI)
Behavioral: Control Treatment Condition (CT)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Group Motivational Interviewing (GMI) For Homeless Veterans In VA Services

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Time Line Follow Back (TLFB) to assess substance use [ Time Frame: one year ] [ Designated as safety issue: No ]
    The TLFB will be used to measure substance use quantity and frequency

  • Time Line Follow Back (TLFB) to assess treatment attendance [ Time Frame: one year ] [ Designated as safety issue: No ]
    An adapted version of the TLFB will be used to assess treatment and 12-step attendance and productive work activities


Secondary Outcome Measures:
  • Addiction Severity Index-Lite (ASI-Lite) to assess addiction severity [ Time Frame: one year ] [ Designated as safety issue: No ]
    The ASI-Lite will be used to measure addiction severity

  • Ethyl Glucurinide (EtG) to assess objective alcohol use [ Time Frame: one year ] [ Designated as safety issue: No ]
    EtG will be used to objectively assess for alcohol use as a confirmatory laboratory measure

  • Short Inventory of Problems Revised (SIP-R) to assess consequence of substance abuse [ Time Frame: one year ] [ Designated as safety issue: No ]
    The SIP-R will be used to assess for consequences related to drinking and drug use

  • Treatment Motivation Questionnaire (TMQ) to assess self reported interest in treatment [ Time Frame: one year ] [ Designated as safety issue: No ]
    The TMQ will be used to measure self-reported interest in attending treatment

  • Brief Symptom Inventory-18 to assess psychological distress [ Time Frame: one year ] [ Designated as safety issue: No ]
    The BSI-18 will be used to assess level of psychological distress

  • Short Form Health Survey-12 (SF-12) to assess functional health status [ Time Frame: one year ] [ Designated as safety issue: No ]
    The SF-12 measures functional health and well-being from the patient's point of view.

  • Quality of Life Survey (QOLS) change in quality of life [ Time Frame: one year ] [ Designated as safety issue: No ]
    Assess quality of life


Estimated Enrollment: 186
Study Start Date: May 2015
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group Motivational Interviewing (GMI)
Group Motivational Interviewing (GMI) participants will receive four structured, back-to-back, 90-min sessions consistent with the central principles and spirit of Motivational Interviewing (MI). GMI, which is based on a manualized protocol, is specifically designed for dually diagnosed Veterans. A focus of the intervention creates awareness of the relationship between the substance use and co-existing psychiatric disorder and the importance of treating both.
Behavioral: Group Motivational Interviewing (GMI)
Participants randomized to Group Motivational Interviewing (GMI) will receive four structured, back-to-back, 90-minute sessions consistent with the central principles and spirit of Motivational Interviewing (MI). GMI, which is based on a manualized protocol, is specifically designed for dually diagnosed Veterans. A focus of the intervention creates awareness of the relationship between the substance use and co-existing psychiatric disorder and the importance of treating both.
Active Comparator: Control Treatment Condition (CT)
Control Treatment Condition (CT): Participants in CT will attend four sessions equal in time and length to Group Motivational Interviewing (GMI) (i.e., 90 minutes) and will involve the following topics: A popular �box activity�: participants will anonymously write evocative questions on slips of paper involving their personal concerns that are placed in a box and, when randomly selected, opened for group discussion (e.g., �How do I talk to my family about my alcohol problem?�), money management with feedback (2 sessions), and cooking-home maintenance.
Behavioral: Control Treatment Condition (CT)
Control Treatment Condition (CT): Participants in CT will attend four sessions equal in time and length to GMI (i.e., 90 minutes) and will involve the following topics: A popular 'box activity': participants will anonymously write evocative questions on slips of paper involving their personal concerns that are placed in a box and, when randomly selected, opened for group discussion (e.g., "How do I talk to my family about my alcohol problem?"), money management with feedback (2 sessions), and cooking-home maintenance.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women Veterans currently in Housing Urban Development-VA Support Housing [HUD-VASH] and Grant and per Diem [GPD]), newly entering the program but not yet housed, or Veterans on the HUD-VASH interest (wait) list.
  • Able to comprehend English.
  • Meets DSM-V criteria for a current substance use disorder and have used substances in the 30 days prior to treatment entry. Participants on medications targeting their substance use must be stabilized on medications for at least 2 weeks before therapy initiation.
  • May meet criteria a mood, anxiety or other psychiatric disorder. Participants on maintenance medications for a mood or anxiety disorder must be stabilized on medications for at least 2 weeks before therapy initiation.
  • Able to adequately provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
  • Willing to commit to 4 group therapy sessions, baseline, 1, 3, and 6 month follow-up assessments.

Exclusion Criteria:

  • Active suicidal or homicidal ideation with a plan as this is likely to require hospitalization or other interventions that could interfere with study participation.
  • Unstable psychiatric condition that is likely to require hospitalization or other interventions that would interfere with study participation.
  • Unstable medical condition or one that may require hospitalization during the course of the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02233738

Contacts
Contact: Elizabeth J Santa Ana, PhD MA BA (843) 789-7168 Elizabeth.SantaAna2@va.gov

Locations
United States, South Carolina
Ralph H Johhnson VA Medical Center Not yet recruiting
Charleston, South Carolina, United States, 29401-5799
Contact: Elizabeth J Santa Ana, PhD MA BA    843-789-7168    Elizabeth.SantaAna2@va.gov   
Contact: Rebekah J Walker, PhD MS    (843) 789-7587    Rebekah.Walker@va.gov   
Sub-Investigator: Clara E. Dismuke, PhD BS         
Principal Investigator: Elizabeth J. Santa Ana, PhD MA BA         
Sponsors and Collaborators
Investigators
Principal Investigator: Elizabeth J. Santa Ana, PhD MA BA Ralph H. Johnson VA Medical Center, Charleston, SC
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT02233738     History of Changes
Other Study ID Numbers: IIR 13-317, IIR 13-317-2
Study First Received: August 21, 2014
Last Updated: February 2, 2015
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Alcoholism
Substance-related disorders
Dual Diagnosis

Additional relevant MeSH terms:
Alcoholism
Substance-Related Disorders
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 28, 2015